L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH

Last updated: March 8, 2023
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

White Cell Disorders

Lymphoma

Bone Marrow Disorder

Treatment

N/A

Clinical Study ID

NCT05775705
BFH20220920001
  • Ages 18-65
  • All Genders

Study Summary

The efficacy and safety of L-DEP (PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated hemophagocytic lymphohistiocytosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
  • EBV-DNA in peripheral blood > 1000 copies/ml or EBER detected in tissue specimens.
  • Age 18~65,gender is not limited.
  • Estimated survival time ≥ 1 month.
  • Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestivetract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >250.
  • Signed informed consent.

Exclusion

Exclusion Criteria:

  • Heart function above grade II (NYHA).
  • Severe myocardial injury:TNT、TNI、CK-MB > 3 ULN.
  • Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicinabove 800mg/m2 or the patients treated with anthracycline induced cardiovasculardisease.
  • Pregnancy or lactating Women.
  • Allergic to pegylated liposomal doxorubicin,etoposide,or PD-1 antibody.
  • Thyroid dysfunction.
  • HIV antibody positivity.
  • Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable),acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibodypositivity, HCV RNA negative acceptable).
  • Participate in other clinical research at the same time.
  • The researchers considered that patients are not suitable for the study.

Study Design

Total Participants: 25
Study Start date:
August 01, 2023
Estimated Completion Date:
October 01, 2026

Study Description

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Currently, HLH-94 or HLH-04 are the standard HLH treatment regimens, which have improved the disease response rate to approximately 70% and increased the 5-year OS rate to 50%. However, approximately, 30% of the patients remain unresponsive to standard therapy, especially if HLH is lymphoma-associated. Therefore, we conduct a prospective clinical study to explore the efficacy and safety of L-DEP (PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated hemophagocytic lymphohistiocytosis.

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

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